Single and Multiple Ascending Dose Study of Aducanumab (BIIB037) in Japanese Participants With Alzheimer's Disease

NCT02434718 | Completed Phase 1 DMC

• 1 other identifier: 221AD104
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 7

Brief Summary

The primary objective of the study is to evaluate the safety and tolerability of single and multiple intravenous (IV) infusions of Aducanumab in Japanese participants with mild to moderate Alzheimer's Disease (AD). The secondary objectives of this study are as follows: To evaluate the serum pharmacokinetics (PK) of Aducanumab after single and multiple intravenous (IV) infusions of Aducanumab; To evaluate the effect of single and multiple IV infusions of Aducanumab on immunogenicity.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (3)

• Incidence and nature of adverse events (AE) / serious adverse events(SAE)

  Up to week 42

• Clinically significant changes in vital signs and 12-lead electrocardiogram (ECG) data; abnormalities in neurological and physical examinations

  Up to week 42

• Brain magnetic resonance imaging (MRI) findings to assess amyloid-related imaging abnormalities (ARIA), including incidence of ARIA-E (edema) or ARIA-H (hemosiderosis)

  Up to week 42

Secondary Outcomes (8)

• Area under the concentration-time curve (AUC) from time zero extrapolated to infinity (AUC0-∞)

  Up to 8 weeks post dosing

• AUC from time zero to time of the last measurable concentration (AUC0-last)

  Up to 8 weeks post dosing

• Maximum observed concentration (Cmax)

  Up to 8 weeks post dosing

• Time to Cmax (Tmax)

  Up to 8 weeks post dosing

• Elimination half-life (t1/2)

  Up to 8 weeks post dosing

Study Arms (4)

Cohort 1

EXPERIMENTAL

IV infusion in cohorts assigned to low dose 1; 1 participant per cohort will receive placebo

Drug: Aducanumab; Drug: Placebo

Cohort 2

EXPERIMENTAL

IV infusion in cohorts assigned to low dose 2; 1 participant per cohort will receive placebo

Drug: Aducanumab; Drug: Placebo

Cohort 3

EXPERIMENTAL

IV infusion in cohorts assigned to high dose; 1 participant per cohort will receive placebo

Drug: Aducanumab; Drug: Placebo

Cohort 4

EXPERIMENTAL

IV infusion in cohorts assigned to mid dose; 1 participant per cohort will receive placebo

Drug: Aducanumab; Drug: Placebo

Interventions

Aducanumab DRUG

As described in the treatment arm

Cohort 1; Cohort 2; Cohort 3; Cohort 4

Placebo DRUG

IV administration of 0.9% sodium chloride

Cohort 1; Cohort 2; Cohort 3; Cohort 4

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be ambulatory
• Must have a clinical diagnosis of mild to moderate AD
• Must be in good health as determined by the Investigator, based on medical history and Screening assessments
• Must have a caregiver who, understands the study and assents to accompany the subject to all study site visits, provide information to the Investigator/study site staff, specifically about cognitive abilities and AEs/SAEs and return for per-protocol follow-up visits and procedures
• Must consent to blood sample collection for deoxyribonucleic acid (DNA; genotyping) and ribonucleic acid (RNA; for potential future analysis).

You may not qualify if:

• Any medical or neurological condition (other than AD) that in the opinion of the Investigator could be a contributing cause of the subject's dementia
• Transient ischemic attack or stroke or any unexplained loss of consciousness within 1 year prior to Screening
• Poorly controlled diabetes mellitus, as defined by having dosage adjustment of diabetic medication within the 3 months prior to Day 1
• History of unstable angina, myocardial infarction, chronic heart failure
• Chronic, uncontrolled hypertension
• History of seizure within 3 years prior to Screening
• History within the past 6 months or evidence of clinically significant psychiatric illness
• History of severe allergic or anaphylactic reactions, or history of hypersensitivity to any of the inactive ingredients in the drug product

Sponsors & Collaborators

• Biogen: lead

Study Sites (7)

Research Site

Tōon, Ehime, Japan

Location

Research Site

Kobe, Hyōgo, Japan

Location

Research Site

Kamakura, Kanagawa, Japan

Location

Research Site

Kanzaki, Saga-ken, Japan

Location

Research Site

Kodaira, Tokoyo, Japan

Location

Research Site

Shinjuku, Tokoyo, Japan

Location

Research Site

Kyoto, Japan

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

aducanumab

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2015
• First Posted: May 5, 2015
• Study Start: June 24, 2015
• Primary Completion: December 9, 2016
• Study Completion: December 9, 2016
• Last Updated: August 21, 2020

Record last verified: 2020-08

Locations

JP (7)